Multi-level School-based Intervention to Improve HPV Vaccine Uptake and Completion in South Africa

Phase 2

Not yet recruiting

• Conditions: HPV
• Interventions: Other: HPV Vaccine Communication Strategy

• Registration Number: NCT05919901
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

Human Papillomavirus (HPV) is the most common sexually transmitted infection globally, and is causally linked to cervical, anogenital, and oropharyngeal cancers. HPV-associated cancers have a disproportionate impact in low-resource settings and nowhere is this evident than in South Africa, which has a uniquely vulnerable population due to the convergence of the largest HIV epidemic globally, with HPV rates of up to 85% in young women under the age of 25. For the clinical trial phase of this study, we intend to evaluate preliminary effects of a communications strategy and key criteria to advance to a full scale hybrid type 2 trial. Our systems-focused approach leverages established partnerships with area schools serving diverse populations who are not always effectively served by traditional healthcare channels.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-18
• Last Update Submitted: 2023-06-18
• Study First Posted: 2023-06-26
• Last Update Posted: 2023-06-26
• Study Start: 2025-01-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• This study will include children enrolled in Grade 5 in participating schools (ages 9-12 years old) in KwaZulu Natal, South Africa, who have no prior history of HPV immunization. We have selected fifth graders for our target population to follow the current Provincial Guidelines. This is in line with National Cervical Guidelines aimed at reaching young people prior to their sexual debut.

We will also be recruiting parents/caregivers of these children, given their role in decision-making. All parents/caregivers will be at least 18 years old. We will also be including adults who are at least 18 years of age, who are employed at participating schools as teachers or school administrators, and others who are engaged in the planning or implementation of the school-based HPV vaccine program (e.g., representatives from the Department of Health, nurses). We have no upper age limit for this population.

Exclusion Criteria

• Children below the age of 9 years old will not be included in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPV Intervention	HPV Vaccine Communication Strategy	-
Active Control	HPV Vaccine Communication Strategy	-

Primary Outcome Measures

Name	Time	Method
Acceptability of the intervention	Six Months	Acceptability will be determined using the Acceptability of Intervention Measure.
Feasibility of delivering the intervention	Six Months	Feasibility will be assessed using the Feasibility of Intervention Measure.

Secondary Outcome Measures

Name	Time	Method
Preliminary Effectiveness of the HPV intervention	Six Months	We will assess HPV vaccine completion at six months

Trial Locations

Locations (1)

University of Witwatersrand Health Consortium; 🇿🇦 Johannesburg, Gautang, South Africa